IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Li cens ing: In 2002, Ca na dian rights were li censed to PanGeo Pharma.
Sensory Organ Agents/Ophthalmologicals
LUCENTIS (ranibizumab) is a monoclonal an ti body, orig i nally de vel oped by Genentech (now part of
Roche, Swit zer land) in col lab o ra tion with li censee Novartis, for the treat ment of wet age-re lated macular
de gen er a tion (AMD). It was first launched by Novartis in Fin land in 2004. Genentech filed a BLA with the
FDA for the treat ment of AMD in 2005 and ap proval was granted in June 2006, when Lucentis was
launched in the USA, its first world mar ket, by Genentech, which holds North Amer i can rights. In 2006, it
was also launched in Aus tria, Swit zer land and Nor way. It was ap proved in the EU in Jan u ary 2007. 2007
saw launches in a num ber of coun tries, in clud ing the UK, Ire land, Ger many, Den mark, In do ne sia, Swe -
den, Bul garia, Po land, Bel gium, Can ada, France, Greece, It aly, Aus tra lia, New Zea land, Spain, Ar gen tina,
Mex ico, Hun gary, Thai land and South Ko rea. In 2008, it was launched in Ku wait, Pa ki stan and Sin ga pore.
In Jan u ary 2009, Novartis noted that Lucentis is now ap proved in more than 70 markets. It was approved
in Japan in January 2009.
Lucentis is the first treat ment for wet AMD that has been shown to im prove vi sion rather than slow vi sion
loss, and is ex pected to be come a gold stan dard treat ment. Novartis is also de vel op ing Lucentis for the
treat ment of di a betic macular edema (DME). In No vem ber 2008, Novartis stated that Lucentis had
shown “suc cess ful re sults in the phase II RE SOLVE study with sta tis ti cally sig nif i cant vi sion im prove ment
com pared to pla cebo in pa tients with DME, an eye con di tion linked with high blood sugar that causes
blind ness. The phase III RE STORE study was started in May 2008 in DME, with a sub mis sion in Europe
planned for 2010.”
In the UK there have been prob lems with NHS fund ing for Lucentis, but in late 2008 Novartis came to an
agree ment with the UK De part ment of Health whereby it agreed to pay for use of the drug be yond 14 in -
jec tions if nec es sary.
Li cens ing: In 2003, Genentech granted Novartis an ex clu sive li cense to de velop and mar ket Lucentis
out side North Amer ica for in di ca tions re lated to dis eases of the eye. Un der the terms of the deal, the com -
pa nies shared cer tain global de vel op ment costs. Genentech will re ceive an upfront fee, mile stone pay -
ments and roy al ties from prod uct sales out side North Amer ica. North Amer i can mar ket ing rights will be
retained by Genentech.
Clin i cal Data: Data from the AN CHOR study, pre sented in 2006, com par ing Lucentis to Visudyne
(verteporfin) photodynamic ther apy (PDT), showed a dif fer ence in mean change in vi sual acu ity of 18 let -
ters for pa tients treated with 0.3mg of Lucentis and 21 let ters for pa tients treated with 0.5mg of Lucentis
from study en try com pared to those treated with PDT at 12 months. In the first year of this two-year
study, pa tients treated with Lucentis gained an av er age of 8.5 let ters in the 0.3mg dose group and 11 let -
ters in the 0.5mg dose group com pared to pa tients treated with PDT, who lost an av er age of 9.5 letters.
QLT (Can ada) is con duct ing a phase II trial, known as RAD I CAL, com par ing Visudyne-Lucentis com bi na -
tion ther a pies with Lucentis monotherapy in 162 sub jects with choroidal neovascularization sec ond ary to
age-re lated macular de gen er a tion. The study is de signed to de ter mine if the com bi na tion ther apy re -
duces retreatment rates com pared with Lucentis monotherapy. Six month re sults re ported in De cem ber
2008 showed that mean cu mu la tive treat ments were lower in the com bi na tion groups than the
monotherapy group.
Com pe ti tion: About one third of pa tients in clin i cal tri als of Lucentis dem on strated im proved vi sion af ter
12 months, giv ing it a firm ad van tage over Pfizer’s ri val VEGF in hib i tor Macugen (pegaptanib). Pfizer ap -
peared to have had the ad van tage of six-weekly dos ing with Macugen, Lucentis has a broader la bel.
Macugen was ap proved by the FDA in 2004 (and in the EU in 2006).
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